NCT00134199

Brief Summary

To evaluate the effect of 6-month administration of CP-945,598 on:

  • weight loss and waist circumference,
  • blood pressure, cholesterol, glucose
  • other biochemical variables like insulin, leptin, ghrelin, adiponectin, PAI 1, TNF-α and hsCRP
  • the relationship between the concentration of the drug on the blood and the above parameters
  • physical and psychosocial functioning, weight related symptoms, treatment satisfaction, appetite/hunger/satiety/craving and mood, anxiety, anhedonia and depression

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
282

participants targeted

Target at P75+ for phase_2 obesity

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_2 obesity

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

August 12, 2009

Status Verified

April 1, 2006

First QC Date

August 22, 2005

Last Update Submit

August 11, 2009

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Determine the effect of various doses of CP 945,598 on body weight in obese subjects after 24 weeks of dosing

Secondary Outcomes (1)

  • Evaluate the safety and tolerability of CP 945,598 in a 26 week outpatient setting;; -Explore the effect of CP 945,598 on: waist circumference, PD measurements of selected biochemical variables related to energy deficit and weight loss includ

Interventions

CP-945,598DRUG
sibutramineDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and/or female subjects without clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12 lead ECG and clinical laboratory tests
  • Body Mass Index (BMI) ³30 and \<40 kg/m2, for subjects with no additional
  • co morbidities; BMI ³27 kg/m2 and \<40 kg/m2, for subjects with co morbidities \[history of essential hypertension and/or dyslipidemia defined as high LDL (³160 mg/dL) or high total cholesterol (³240 mg/dL)\];

You may not qualify if:

  • Subjects with resting sitting systolic blood pressure of 140 mmHg or greater or diastolic blood pressure of 90 mmHg or greater.
  • Subjects with type 2 diabetes or fasting blood glucose concentration ³126 mg/dL;
  • Subjects with a history of eating disorders like anorexia nervosa or bulimia nervosa
  • Subjects on prescription and non-prescription appetite or weight modifying drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Pfizer Investigational Site

Clearwater, Florida, 33761, United States

Location

Pfizer Investigational Site

Kissimmee, Florida, 34741, United States

Location

Pfizer Investigational Site

Orlando, Florida, 32809, United States

Location

Pfizer Investigational Site

Lexington, Kentucky, 40509, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, 40213, United States

Location

Pfizer Investigational Site

Baton Rouge, Louisiana, 70808, United States

Location

Pfizer Investigational Site

Milford, Massachusetts, 01757, United States

Location

Pfizer Investigational Site

New York, New York, 10021, United States

Location

Pfizer Investigational Site

Charlotte, North Carolina, 28211, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37203, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75231, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75247, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229, United States

Location

Pfizer Investigational Site

Tacoma, Washington, 98403, United States

Location

Pfizer Investigational Site

Tacoma, Washington, 98418, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

sibutramine

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 22, 2005

First Posted

August 24, 2005

Study Start

March 1, 2005

Study Completion

November 1, 2005

Last Updated

August 12, 2009

Record last verified: 2006-04

Locations

US(15)